— HUTCHMED unveils its innovative ATTC platform, potentially providing precision oncology with synergistic dual-mechanism of action — — Lead candidate HMPL-A251 harnesses a selective PI3K/PIKK inhibitor payload, demonstrating promising preclinical efficacy and safety — — Progress in global and China trials, including FRUSICA-2, SANOVO, surufatinib’s PDAC and fanregratinib’s IHCC studies, advances HUTCHMED’s late-stage pipeline — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 02, 2025 (GLOBE NEWSWIRE) - ...

HAYWARD, Calif., Nov. 02, 2025 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or the “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (“ddRNAi”) platform, today announced that it will provide an update on the six treated patients from Cohort 1 of its Phase 1b/2a Clinical Study of BB-301 being investigated for the treatment of Oculopharyngeal Muscular ...

Underground core drilling at Tomingley is focused on defining extensions to resources as well as improving confidence of Inferred Resources at McLeans and the Western Monzodiorite domain at Roswell. Both McLeans and the Western Monzodiorite are immediately adjacent to existing underground infrastructure. Underground drilling comprising of 9 diamond holes for a total of 3,247 metres was completed to improve the confidence of the Inferred Resource at McLeans. This drilling discovered a second andesite with s ...

Leanne Heywood was most recently a senior international copper marketing executive with Rio TintoPERTH, Australia, Nov. 02, 2025 (GLOBE NEWSWIRE) -- FireFly Metals Ltd (ASX/TSX: FFM) (FireFly or the Company) is pleased to announce the appointment of highly regarded resources executive and company director Leanne Heywood as an Independent Non-Executive Director. Ms Heywood, who is a Fellow of accounting body CPA Australia, has significant experience as an international executive in the mining sector. Most re ...

监管审批状态 - 美国食品药品监督管理局针对AVT05的生物制品许可申请发出完整回复函 [1] - 完整回复函指出 必须满意解决2025年7月FDA对雷克雅未克生产基地检查中发现的某些缺陷 该BLA才能获批 [2] - FDA未在申请中发现其他缺陷 该生产基地目前仍获FDA批准生产并继续供应已商业化的产品 [2] 产品市场前景 - AVT05是Simponi®（戈利木单抗）的生物类似药候选产品 提供预充式注射器和自动注射器两种剂型 [1] - 2025年上半年 Simponi在美国的销售额低于3亿美元 [3] - 目前美国FDA尚未批准任何Simponi的生物类似药 [3] - 公司致力于解决未决问题 并与FDA继续合作 以将这一首仿生物类似药带给美国患者 [4] 公司财务指引更新 - 收到完整回复函后 公司重新评估2025年展望 总营收预期下调至5.7亿至6亿美元 调整后税息折旧及摊销前利润预期下调至1.3亿至1.5亿美元 [5] - 调整后税息折旧及摊销前利润预期下调主要由于预计将继续投入资金解决某些生产设施问题 这同时需要暂时放缓生产速度 [5] - 这些投资也将支持公司未来的增长计划和新产品上市 [5] 公司业务概况 - 公司是一家全球生物技术公司 专注于为全球患者开发和制造生物类似药 [6] - 公司当前管线包括八个已披露的生物类似药候选产品 旨在治疗自身免疫性疾病、眼部疾病、骨质疏松症、呼吸系统疾病和癌症 [6] - 公司已建立战略商业合作伙伴网络 覆盖美国、欧洲、日本、中国、其他亚洲国家以及南美洲、非洲和中东的大部分地区 [6]

REYKJAVIK, ICELAND (November 2, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi® (golimumab). The CRL noted that certain deficiencies, which were ...

公司临床数据发布安排 - 公司将于2025年11月3日东部时间上午8:00举行网络直播，报告ANTLER 1期临床试验的新数据，该试验评估vispa-cel在复发或难治性B细胞非霍奇金淋巴瘤患者中的应用 [1] - 网络直播将首次报告CaMMouflage 1期临床试验的初步临床数据，该试验评估CB-011在复发或难治性多发性骨髓瘤患者中的应用 [1] - 公司将报告vispa-cel预期的关键性3期试验设计以及CB-011后续临床开发计划 [1] 核心产品管线vispa-cel - vispacabtagene regedleucel是一种用于治疗复发或难治性B细胞非霍奇金淋巴瘤的同种异体抗CD19 CAR-T细胞疗法 [3] - 据公司所知，vispa-cel是临床中首个带有PD-1敲除的同种异体CAR-T细胞疗法，该基因组编辑策略旨在通过限制CAR-T细胞过早耗竭来增强其活性 [3] - 美国FDA已授予vispa-cel用于B-NHL的再生医学先进疗法、孤儿药和快速通道资格认定 [3] 核心产品管线CB-011 - CB-011是一种用于治疗复发或难治性多发性骨髓瘤的同种异体抗BCMA CAR-T细胞疗法，正在CaMMouflage 1期试验中进行评估 [4] - 据公司所知，CB-011是临床中首个通过B2M敲除并插入B2M–HLA-E融合蛋白的免疫伪装策略来避免免疫介导的排斥的同种异体CAR-T细胞疗法 [4] - CB-011已获得美国FDA的快速通道和孤儿药资格认定 [4] 公司技术平台与战略重点 - 公司是一家临床阶段的CRISPR基因组编辑生物制药公司，专注于为患有严重疾病的患者开发变革性疗法 [5] - 公司的基因组编辑平台，包括其Cas12a chRDNA技术，能够以卓越的精确度开发经过“装甲”改造的细胞疗法，从而可能改善对疾病的活性 [5] - 公司专注于将vispa-cel和CB-011作为现成CAR-T细胞疗法进行开发，这些疗法有潜力为血液恶性肿瘤患者提供广泛的治疗可及性和快速治疗 [5]

LUXEMBOURG, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Tenaris S.A. (NYSE and Mexico: TS and EXM Italy: TEN) (“Tenaris”) announced today that pursuant to its USD 1.2 billion Share Buyback Program (the “Program”) announced on May 27, 2025, it has entered into a non-discretionary buyback agreement with a primary financial institution (the “Bank”) for the execution of its second tranche, covering up to the remainder USD 600 million of the Program (excluding customary transaction fees). This second tranche shall start o ...

MHRA response is based on the Phase 3 DRAGON interim analysis results Topline final data expected in Q4 2025 SAN DIEGO, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed to accept a Conditional Marketing Authorization appl ...

SHENZHEN, China, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Fangzhou Inc. (“Fangzhou” or the “Company”) (HKEX: 06086), a leader in AI-driven Internet healthcare solutions, was presented with a Generative AI Service Filing Certificate at the first Guangdong Provincial LLM Filing Conference in Shenzhen. At the event, Dr. Xie Fangmin, Founder, Chairman, and CEO of Fangzhou, remarked: “The successful launch of the ‘XingJie’ Large Language Model (‘XJ LLM’) marks another milestone in Fangzhou’s advancement of AI-driven ch ...